FDA Enforcement
Class II
Terminated
Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244
Recall: Z-0455-2019
·
Reported November 21, 2018
Enforcement
- Recall Number
- Z-0455-2019
- Event ID
- 81456
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Straumann Manufacturing, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 21, 2018
- Initiation Date
- October 2, 2018
- Classification Date
- November 13, 2018
- Termination Date
- January 28, 2019
- Address
- 60 Minuteman Rd, Andover, MA, 01810-1008, United States
Description
Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244
Reason
Laser engraved label does not match with the item in the package
Code Info
Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510
Distribution
US nationwide distribution in the states of GA, TX , VA.
Quantity
21 units